Blog
RSS FeedPosted by Michael Wonder on 28 Jan 2025
Enhertu approved in the US as first HER2 directed therapy for patients with HER2 low or HER2 ultralow metastatic breast cancer following disease progression after one or more endocrine therapies
27 January 2025 - Based on DESTINY-Breast06 phase 3 trial results which showed Enhertu demonstrated superiority versus chemotherapy with a ...
Posted by Michael Wonder on 27 Jan 2025
FDA grants priority review to Merck’s application for Welireg (belzutifan) for the treatment of patients with advanced pheochromocytoma and paraganglioma
27 January 2025 - Acceptance based on objective response rate data from the Phase 2 LITESPARK-015 trial evaluating WELIREG in certain ...
Posted by Michael Wonder on 24 Jan 2025
Clarity receives US FDA fast track designation for Cu 64 SAR-bisPSMA in biochemical recurrence of prostate cancer
24 January 2025 - Clarity Pharmaceuticals is pleased to announce that the US FDA has granted fast track designation for ...
Posted by Michael Wonder on 23 Jan 2025
Medexus announces FDA approval of Grapafex (treosulphan) for injection
22 January 2025 - Medexus will target a commercial launch in 1H CY2025; potential for annual product-level revenue to exceed ...
Posted by Michael Wonder on 22 Jan 2025
Sarclisa approved in the EU as the first anti-CD38 therapy in combination with standard of care VRd to treat transplant-ineligible newly diagnosed multiple myeloma
22 January 2025 - Approval is based on positive results from the IMROZ Phase 3 study, demonstrating Sarclisa in combination with ...
Posted by Michael Wonder on 22 Jan 2025
Abiraterone acetate with niraparib tosylate monohydrate and prednisone for untreated hormone-relapsed metastatic prostate cancer
22 January 2025 - NICE is unable to make a recommendation on the use in the NHS of abiraterone acetate with ...
Posted by Michael Wonder on 22 Jan 2025
Replimune announces biologics license application acceptance and priority review for RP1 for the treatment of advanced melanoma
21 January 2025 - PDUFA action date of 22 July 2025, with priority review. ...
Posted by Michael Wonder on 21 Jan 2025
NICE has made six times more lung cancer treatment recommendations over the past ten years than in the previous decade
21 January 2025 - We have also recommended osimertinib for routine use on the NHS today. ...
Posted by Michael Wonder on 21 Jan 2025
European Commission approves Lazcluze (lazertinib) in combination with Rybrevant (amivantamab) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
21 January 2025 - Latest topline data from the Phase 3 MARIPOSA study shows amivantamab plus lazertinib is the first regimen ...
Posted by Michael Wonder on 21 Jan 2025
Anti-PD-L1 tagitanlimab approved for marketing by the National Medical Products Administration
20 January 2025 - The board of directors of Sichuan Kelun-Biotech Biopharmaceutical is pleased to announce that the Company received ...
Posted by Michael Wonder on 21 Jan 2025
Albertan with rare blood cancer calls on Health Canada to approve life-saving drug
20 January 2025 - An Alberta woman living with a rare form of blood cancer is calling on Health Canada ...
Posted by Michael Wonder on 21 Jan 2025
Takeda's Fruzaqla (fruquintinib) receives Health Canada market authorisation for metastatic colorectal cancer
20 January 2025 - Positive reimbursement recommendations by Canada's Drug Agency and Institut National d'excellence en Santé et Services Sociaux. ...
Posted by Michael Wonder on 21 Jan 2025
Immunotherapy Qarziba to be reimbursed for high-risk neuroblastoma patients starting next month
28 November 2024 - The treatment landscape for neuroblastoma, the most common cancer in children outside of blood and brain ...
Posted by Michael Wonder on 20 Jan 2025
European Commission expands Jemperli (dostarlimab) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer
20 January 2025 - Expanded approval includes MMRp/MSS tumours, which represent approximately 75% of endometrial cancer cases. ...
Posted by Michael Wonder on 20 Jan 2025
Handok's AML treatment Vyxeos receives insurance coverage in Korea
2 December 2024 - Handok said Monday that its acute myeloid leukaemia treatment, Vyxeos liposomal injection (cytosine arabinoside and daunorubicin ...